He said, “Most of the time we don’t get comments on regulations in response to those notifications,” but the government is required under the Regulatory Flexibility Act to review rules no later than 10 years after the final rule has been put in place.
According to the notification, “FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in section 165.110; (2) the nature of complaints or comments received concerning the regulations in section 165.110; (3) the complexity of the regulations; (4) the extent to which the regulations in section 165.110 overlap, duplicate, or conflict with other federal rules, and to the extent feasible, with state or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in section 165.110.”
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